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Checkpoint Inhibitor

Tumor-Treating Fields + Immunotherapy for Uveal Melanoma

Phase 1
Recruiting
Led By Justin Moser, MD
Research Sponsored by HonorHealth Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
Normal organ and marrow function
Must not have
History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy
Patient is unwilling or unable to comply with study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initiation of study treatment and through study completion, up to 1 year
Awards & highlights

Summary

This trial suggests that Tumor Treating Fields may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.

Who is the study for?
This trial is for adults with metastatic uveal melanoma, mainly affecting the liver. Participants must be in good physical condition (ECOG 0-1), have a life expectancy of at least 3 months, and normal organ/marrow function. Women of childbearing potential must test negative for pregnancy and use contraception. Excluded are those with active autoimmune diseases requiring strong medication, recent cancer treatments, or severe reactions to immune checkpoint inhibitors.Check my eligibility
What is being tested?
The study tests Tumor-Treating Fields targeting liver metastases combined with Nivolumab and Ipilimumab—two immunotherapy drugs—in patients with metastatic uveal melanoma. The goal is to see if this combination improves patient outcomes compared to current treatments.See study design
What are the potential side effects?
Possible side effects include skin irritation from the device used for Tumor-Treating Fields, as well as typical immune therapy-related issues like inflammation in organs, fatigue, digestive problems, skin reactions and potential worsening of autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of eye melanoma that has spread mainly to my liver.
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My organs and bone marrow are functioning normally.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a severe reaction to previous immunotherapy.
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I am willing and able to follow the study's procedures.
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I haven't had any cancer treatments in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of study treatment and through study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of study treatment and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Overall Safety
Secondary outcome measures
Overall Survival Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: TTF Plus ChemotherapyExperimental Treatment3 Interventions
Novacure Optune with Opdivo and Yervoy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yervoy
2012
Completed Phase 2
~700
Opdivo
2017
Completed Phase 2
~110

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Uveal Melanoma include Tumor Treating Fields (TTFields), immune checkpoint inhibitors, and local therapies like radiation. TTFields work by disrupting cell division through electric fields, which can inhibit tumor growth and potentially improve outcomes. Immune checkpoint inhibitors, such as nivolumab and ipilimumab, enhance the body's immune response against cancer cells. Local therapies, including radiation (e.g., proton therapy and plaque brachytherapy), target the tumor directly while sparing surrounding tissues. These treatments are crucial for Uveal Melanoma patients as they offer targeted approaches to control tumor growth, improve survival rates, and maintain quality of life.
[Antitumor electro-chemotherapy].

Find a Location

Who is running the clinical trial?

NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,714 Total Patients Enrolled
HonorHealth Research InstituteLead Sponsor
25 Previous Clinical Trials
896 Total Patients Enrolled
Justin Moser, MDPrincipal InvestigatorHonorHealth Research Institute
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Uveal Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05004025 — Phase 1
~3 spots leftby Aug 2025
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